Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD
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|ClinicalTrials.gov Identifier: NCT03633799|
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Women at Risk for Pregnancy||Drug: VeraCept||Phase 3|
Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years
Number of Subjects:
Approximately 1,605 subjects will be enrolled into the study
Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study.
The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index.
- Pearl Index at Years 4 and 5, as well as cumulatively through Years 4 and 5.
- Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4 and 5
Study drug placement:
- Ease of VeraCept placement
- Placement success
- Serious adverse events (SAEs)
- Adverse events (AEs)
- Pelvic infection (pelvic inflammatory disease (PID) or endometritis)
- Ectopic pregnancies
- Uterine perforations
- Abdominal pain
- Expulsion rates at Years 1, 2, 3, 4 and 5
- Bleeding and spotting patterns
- Insertion pain assessed immediately after insertion
- Continuation rates at Years 1, 2, 3, 4 and 5
- Reasons for discontinuation Return to fertility
- Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant. Subjects who desire pregnancy after having VeraCept removed will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1605 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||VeraCept Intrauterine Device (IUD)|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept™, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||October 2024|
VeraCept™ Intrauterine Contraceptive
VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
- contraceptive efficacy through 3 years of use [ Time Frame: through 3 years of use ]contraceptive efficacy through 3 years of use, as assessed by the Pearl Index
- Contraceptive efficacy at Years 4 and 5 [ Time Frame: Years 4 and 5 and cumulatively through Years 4 and 5 ]Pearl Index will be calculated for Years 4 and 5, as well as cumulatively through Years 4 and 5
- cumulative pregnancy percentage [ Time Frame: Years 1 through 5 ]A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage for Years 1 through 5
- Ease of VeraCept placement [ Time Frame: Visit 1 (Day 1) / VeraCept placement ]Ease of VeraCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard).
- VeraCept Placement success [ Time Frame: Visit 1 (Day 1) / VeraCept placement ]The number and percentage of subjects with either a successful or unsuccessful placement will be summarized for the ITT and Safety populations.
- Incidence of AEs and SAEs [ Time Frame: 5 years ]Incidence of AEs and SAEs will be summarized for the ITT population, as well as for the Safety population for all subjects and the 36 to 45-year-old safety sub-population.
- Bleeding and spotting patterns [ Time Frame: Through year 1 ]Bleeding and spotting patterns will be summarized for the ECYC population for the first year of treatment by the number of days in each 28-day cycle with bleeding or spotting, bleeding only and spotting only
- Insertion pain assessed immediately after insertion [ Time Frame: Visit 1 (Day 1), immediately after insertion ]Summarized for subjects with and without prior prophylactic pain medication as measured by an 11-Point Numeric Pain Rating Scale. The scale being 0 - 10 with 0 being no pain and 10 being the worse pain
- Cumulative VeraCept continuation rates [ Time Frame: Years 1 through 5 ]
Cumulative VeraCept continuation rates for Years 1 through 5 will be summarized using Kaplan-Meier methods for the Safety population. The number and percentage of subjects with each reason for discontinuation will be summarized.
Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.
- Cumulative VeraCept expulsion rates [ Time Frame: Years 1 through 5 ]Cumulative VeraCept expulsion rates for Years 1 through 5 will be summarized using Kaplan-Meier methods for the Safety population.
- Return to Fertility. Only for subjects requesting VeraCept removal to become pregnant. [ Time Frame: Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first. ]The number and percentage of subjects with each return to fertility response will be summarized for the Safety population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633799
|Contact: Monique Gagnonemail@example.com|
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